Kornimate/medical-research-clean huggingface dataset:
membrane sweeping in early labor and delivery outcomes

Conditions: Early Labor

Summary: membrane sweeping is a routine procedure in obstetrics in term patients. it has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. the goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.

this is a non-blinded randomized controlled trial. participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. patients with a term, singleton pregnancy who present with regular, painful contractions and a bishop score \< 7 will be recruited to the study. a random number generator will be used to create a list of random binary numbers. if the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. this would be done with at least one rotation counterclockwise and one rotation clockwise. those not assigned to membrane sweeping will not have an additional exam. patients will then be managed as per their primary obstetrics (ob) provider with the exception of no further membrane sweeping throughout the labor course. participants are only required to participate during initial evaluation and randomization. no extra study visits are required. due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial. no therapy will be withheld for any patients. their labor course will be managed as per their primary provider using standards of care. non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping. patients will be removed from the study if they chose to withdraw their participation. participants will resume care as normal regardless of withdrawing study participation.

Eligibility criteria:
inclusion criteria: * singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, bishop score \<7, english or spanish speaking exclusion criteria: * prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping
a study to evaluate asp8232 as add-on therapy to angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) in reducing albuminuria in patients with type 2 diabetes and chronic kidney disease

Conditions: Chronic Kidney Disease; Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy of asp8232 in reducing urinary albumin to creatinine ratio (uacr) in subjects with type 2 diabetes mellitus (t2dm) and chronic kidney disease (ckd) at 12 weeks compared to placebo.


Eligibility criteria:
inclusion criteria: * subject must have an estimated glomerular filtration rate (egfr) ) \>=25 and \<75 ml/min/1.73m2. * subject must have a documented diagnosis of t2dm and received anti-diabetic medication (oral and/or parenteral) for at least 1 year prior to screening * subject's glycated hemoglobin (hba1c) level is \< 11.0% (\<97 mmol/mol) at screening. * subject is on a stable therapy with an angiotensin-converting-enzyme (ace) inhibitor or angiotensin receptor blockers (arb) for at least 3 months prior to screening. * subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin d receptor activators at screening needs to be on stable therapy for at least 3 months prior to screening. subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening. * if the subject has been subjected to specific dietary interventions then this has to be stable over the past 3 months prior to screening visit. * subject's uacr is ≥ 200 and ≤ 3000 mg/g in a first morning void (fmv) sample at screening and the geometric mean uacr of all fmv samples at visit 4 and at visit 5 is ≥ 200 and ≤ 3000 mg/g and the uacr in at least 3 fmv samples at visit 4 and visit 5 is ≥ 200 mg/g. exclusion criteria: * subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation). * subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy. * subject's renal impairment and/or albuminuria is considered to be of other origin than diabetic kidney disease. * subject has known (auto-) immune disorder and/or received immunosuppression for more than 2 weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study. * subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization * subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology. * subject has a sitting systolic blood pressure (sbp) \ 160 mmhg and/or a diastolic blood pressure (dbp) \>90 mmhg at screening.

Keywords: chronic kidney disease type 2 diabetes asp8232
a phase ii study to evaluate the efficacy and safety of shr-1314 in lupus nephritis

Conditions: Lupus Nephritis

Summary: to demonstrate the efficacy of shr-1314 at week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h upcr, compared to placebo. the study will also assess the safety and tolerability of shr-1314 in the patient population over the study period.


Eligibility criteria:
inclusion criteria: 1. chinese adult pts (18-65yr), male or female 2. bmi≥18 kg/m2 and ≤ 35kg/m2 3. confirmed diagnosis of ln, renal biopsy report data is within 3-months prior to the date of icf is first signed 3.1 biopsy-proven proliferative lupus nephritis class iii or class iv, either with or without the presence of class v, using the 2003 isn/rps criteria. 3.2 24h upcr ≥ 1 at screening. 3.3 24h upr ≥ 1.0 g/d，≤ 3.5 g/d. 3.4 egfr \> 45ml/min/1.73m2. 4. sledai-2k≥8. exclusion criteria: 1. significant medical problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric sle (npsle) 2. subjects who have previously treated by both cyc and mmf (or other forms of mycophenolate) 3. with a hhistory of using 60 mg/d prednisolone (or equivalent dose) for more than 3 months prior to baseline 4. history of inflammatory bowel disease or have other ongoing active autoimmune diseases 5. required management of acute or chronic infections within the past 8 weeks. 6. at screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. history of congestive heart failure (new york heart association \[nyha\] functional classification ≥iii), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the investigator prevents the subject from participating in the study. 8. history of depression and/or suicidal ideation or any suicidal behavior based on an assessment using the columbina suicide severity rating scale (c-ssrs) at screening and baseline . the subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide 9. receipt of any il-17/il-17r targeted therapy within the past year. 10. those who have participated in any clinical study for any drug or medical device within 3 months before screening. 11. tested positive for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. 12. all subjects will be tested for tuberculosis status using igra and x-ray test. subjects with active or latent tuberculosis will be excluded 13. history of severe allergic reaction to contrast agents or biological medicines.current drug or alcohol abuse or dependence. 14. history of severe allergic reaction to contrast agents or biological medicines.current drug or alcohol abuse or dependence. 15. pregnant or nursing..
risk of chronic kidney disease in bronchial asthma

Conditions: Bronchial Asthma

Summary: the study aims to determine the frequency and factors associated with chronic kidney disease among asthmatic patients in order to determine persons who are at risk of developing chronic kidney disease and require strict follow up in long run , to evaluate severity of asthma as a potential risk for developing kidney injury , to evaluate relationship between different inflammatory markers with severity of asthma and risk of deneloping chronic kidney disease


Eligibility criteria:
inclusion criteria: * all children diagnosed as bronchial asthma at sohag university hospitals from age of 2 years to age of 18 years and donot have any associated disease exclusion criteria: * persons who have any chronic illness persons who have any associated disease with bronchial asthma persons who missing clinical and laboratory investigations persons who refusing to give written informed consent for the study
sound and vision: a collaboration between service-users, artists and the public to explore the lived experience of hallucinations

Conditions: Schizophrenia; Parkinson Disease; Hallucinations

Summary: sound and vision: a collaboration between service-users, artists and the public to explore the lived experience of hallucinations

sound and vision will pair local artists with patients who have had hallucinations to create art pieces that represent their hallucinatory experiences. patients with diagnoses of schizophrenia and parkinson's disease will be invited to take part in participating national health service (nhs) clinics, to capture and compare a wide range of hallucinatory experiences. patients will meet with artists on several occasions who will then develop the piece, which may be a painting, drawing, or other media that the artist and service-user jointly select. completed artworks will be the centrepiece for an exhibition at united kingdom (uk) science festivals and a digital (on-line) presentation. the exhibition will be accompanied by researchers explaining the brain science of hallucinations, recordings of patients and artists describing their experience with hallucinations and the process of developing the artworks, booklets cataloguing the exhibition, and art materials available for artistic expression of their own experiences. a digital compendium of the artworks and supporting material will be publicly available alongside the opportunity to complete an online survey exploring the themes of the artworks and collecting information on personal experiences. the objectives are to engage the public in an appreciation of the experience of hallucinations and their prevalence across many common mental health and neurodegenerative disorders, as well as an experience many people will share without ever being diagnosed. the exhibition will also encourage the public to share their own experiences through the online questionnaires creating a platform to begin to improve the understanding of the diversity of hallucination-like experiences in the general population.

Eligibility criteria:
no particular inclusion or exclusion criteria

Keywords: hallucination
playtime open globe injuries in children

Conditions: Eye Trauma

Summary: this study investigated the epidemiology, aetiologies, and complications of playtime open-globe injuries in children at the assiut university hospital, egypt, between january to july 2016.

this prospective study was conducted at the department of ophthalmology, assiut university hospital, which is the largest tertiary referral hospital in upper egypt and provides 24-hour ophthalmic emergency services for six governorates. the study included all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period. demographic information (age and sex), the site and mechanism of injury, the site of ocular laceration (corneal, scleral or corneoscleral) and associated complications were recorded and analysed.

Eligibility criteria:
inclusion criteria: * all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period (january-july 2016). exclusion criteria: * open globe injuries in patients olader than 18 years. * closed globe injuries
ruxolitinib and methylprednisolone as a first-line treatment for macrophage activation syndrome

Conditions: Macrophage Activation Syndrome

Summary: the present study was a single-center, prospective, non-comparative in which macrophage activation syndrome patients were selected as the main subjects to evaluate the effect and safety of ruxolitinib and methylprednisolone regimens as the first-line therapy .


Eligibility criteria:
inclusion criteria: 1. meet hemophagocytic lymphohistiocytosis (hlh)-04 diagnostic criteria; patients were diagnosed with autoimmune disease associated hlh (macrophage activation syndrome, mas). 2. no hlh induction therapy was performed. 3. the expected survival time is more than 1 month. 4. serum creatinine ≤ 1.5 times normal；serum human immunodeficiency virus(hiv) antigen or antibody negative； hepatitis c virus (hcv) antibody is negative, or hcv antibody is positive, but hcv rna is negative；hbv copies less than 1e+03 copies/ml. 5. total bilirubin ≤10 times the upper limit of normal; serum creatinine ≤1.5 times the normal value 6. the left ventricular ejection fraction (lvef) was normal. 7. no uncontrollable infection. 8. contraception for both male or female. 9. informed consent obtained. exclusion criteria: 1. pregnancy or lactating women； 2. allergic to ruxolitinib； 3. active bleeding of the internal organs； 4. uncontrollable infection； 5. serious mental illness; 6. non-melanoma skin cancer history; 7. patients unable to comply during the trial and/or follow-up phase; 8. participate in other clinical research at the same time.
comparison of two neuromuscular anesthetics reversal in obese patient undergoing bariatric surgery

Conditions: Anesthesia; Surgery

Summary: the study is a prospective, single center, double arm study aiming at the comparison of 2 commercial neuromuscular block reversal drugs: neostigmine (cooper s.a.) and sugammadex (msd). a faster recovery from neuromuscular block is expected for patients receiving sugammadex and this protocol is of high importance for anesthesia of morbid obese patients during bariatric surgery.


Eligibility criteria:
inclusion criteria: 1. morbidly obese male or female patients in the age 20-65 that are candidates for bariatric surgery. 2. patients that can read and understand the fundamental nature of the clinical protocol. 3. patients must sign the informed consent form. exclusion criteria: 1. patients treated with drugs that might interact with rocuronium. 2. patients with history of malignant hyperthermia. 3. patients with significant renal disease. 4. patients with a known allergy to one of the drugs used during anesthesia. 5. patients with known muscular disease. 6. patients with severe cardiovascular disease (nyha\>2) 7. breast feeding patients 8. patients refusing to follow the clinical protocol. 9. patients participating in a different clinical trial. 10. patients refusing to sign the informed consent form 11. physician's objection.

Keywords: morbid obesity bariatric surgery neuromuscular block reversal
safety, tolerability and evidence of activity study of ubx1325 in patients with diabetic macular edema (behold)

Conditions: Diabetic Macular Edema (DME)

Summary: this study is intended to assess the exposure, safety, biological activity, and durability of ubx1325, a phosphate pro-drug, and its active parent molecule (ubx0601) following a single intravitreal (ivt) injection of ubx1325 in patients with diabetic macular edema (dme).

this is a phase 2a proof-of-concept (poc) study. the study will enroll approximately 62 patients randomized 1:1 into either the ubx1325 or sham study arms, in order to assess safety and tolerability as well as impact on visual function and retinal anatomy. patients will be followed for 24 weeks for the primary outcome measure and for an additional 24 weeks (48 weeks total) for the secondary outcome measures.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * diabetic retinopathy patients (nonproliferative (npdr) and proliferative (pdr)) with dme (etdrs-drss score at 65c \[or dr severity level of 8\]or less severe as determined by a central reading center), who had at least 2 anti-vegf intravitreal (ivt) injections (one or more of the following agents: aflibercept, bevacizumab or ranibizumab) in the preceding 6 months prior to day 1, with the last anti-vegf given between 3 and 6 weeks prior to day 1. * center-involved dme with central subfield thickness (cst) ≥300 µm on sd-oct at screening * bcva in the study eye (most affected) of 73 to 20 etdrs letters (equivalent to 20/40 to 20/400 on the snellen chart) at screening and at day 1. exclusion criteria: * concurrent disease in the study eye or structural damage, other than dme, that could compromise bcva, prevent bcva improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or color fundus photography (cfp) in the study eye. * any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening * history of vitreous hemorrhage in the study eye within 2 months prior to screening * any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study * significant media opacities, including cataract, which might interfere with va, assessment of toxicity, or fundus imaging

Keywords: retinal disease macular edema diabetes mellitus diabetic macular edema
cognitive enhancement in bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to examine whether the medication pramipexole (mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.

to address the primary aim, the study is an eight-week, randomized, double-blind, placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar i and ii disorder (bpd) patients, who demonstrate cognitive impairment.

Eligibility criteria:
inclusion criteria: * subjects between 18 and 65 years of age, who meet diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for bpd i or ii (by scid) and confirmed in the diagnostic consensus conference will be included. * subjects must also meet criteria for euthymia described above. * all subjects must be taking a standard mood stabilizer at a stable therapeutic dose (i.e. lithium, carbamazepine, valproate, lamotrigine). exclusion criteria: * subjects with a history of central nervous system (cns) trauma, neurological disorder, attention deficit hyperactivity disorder (adhd), or learning disability will be excluded. * subjects with a dsm-iv diagnosis of current or recent substance abuse or dependence (in the previous 1 month) will be excluded. * moreover, subjects with rapid-cycling during the past year will be excluded (based on scid). * any subject with an active, unstable medical problem that may interfere with cognition will be excluded based on the investigator's judgment. * while medication status is an important consideration in any study of bipolar disorder, the exclusion of patients taking any medication is not practical, given the high prevalence of combination pharmacotherapy for bipolar disorder. to help control for medication effects on cognition, we plan to limit the types of medications allowed by excluding certain medications with a known impact on cognitive performance. * subjects taking clozapine will be excluded due to it's potential overlapping mechanisms of action with pramipexole. * subjects taking prescription or over-the counter medications may also be excluded if these medications have been shown to impact cognition (i.e. diphenhydramine). * the use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of neurocognitive testing will not be allowed. in addition, patients taking topiramate, tricyclic antidepressants, or anticholinergic medications that are known to impact cognition will be excluded from participation. * subjects taking any medications that are known to interact with pramipexole (i.e. zantac, tagamet, reglan, benemid, probalan, compazine, phenergan, quinidine, selegiline, verapamil, and any other medication with a known interaction) will also be excluded.
study of mk0869 for the prevention of chemotherapy-induced nausea and vomiting (0869-071)(completed)

Conditions: Nausea; Vomiting; Breast Neoplasms

Summary: the purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. * patient must have completed participation in the main study for this protocol. exclusion criteria: * patient has a central nervous system malignancy. * patient will receive radiation to the abdomen or pelvis.

Keywords: chemotherapy-induced nausea and vomiting